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This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on the periapical bone healing and further root development of infected immature permanent teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as scaffold, in the control group REP without L-PRF is performed .
Regenerative endodontic procedures are biologically based procedures designed to restore function of a damaged and nonfunctioning pulp by stimulation of existing stem and progenitor cells present in the root canal and/or the introduction and stimulation of new stem and dental pulp progenitor cells into the root canal under conditions that are favorable to their differentiation and reestablishment of function. L-PRF has the potential advantage of creating a bioactive construct that stimulates the local environment for differentiation and proliferation of these stem and progenitor cells. We have designed this confirmatory study to test the hypothesis that the use of L-PRF in REP of infected permanent immature teeth will accelerate periapical bone healing and stimulate the root maturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REP with L-PRF | Experimental | The first REP session will be performed as described by Diogenes et al. (2013). For the second REP-session a venipunction will be performed before the endodontic treatment. 2 to 4 tubes of blood will be collected per tooth. These blood samples will be put into a centrifuge for 12 minutes at 2700 rpm. Fibrin clots will be collected after centrifugation and inserted in the root canal with endodontic pluggers. Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration. |
|
| REP | Active Comparator | A REP will be performed on immature infected permanent teeth, as described in the protocol of Diogenes et al. (2013). Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REP with L-PRF | Procedure |
| ||
| REP |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of periapical bone healing, measured on intra-oral bidimensional radiographs. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of root development or maturogenesis,by measuring: | on intra-oral bidimensional radiographs: the increase in root canal wall thickness. | 3 years |
| Amount of root development or maturogenesis,by measuring: |
| Measure | Description | Time Frame |
|---|---|---|
| On conebeam CT (tridimensional measuring): the amount of periapical bone healing, increase in root canal wall thickness and root canal length. (composite) | 3 years | |
| Patient related outcome, measured by a questionnaire | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Lambrechts, Prof, Dr | Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Megabite Dental Office | Brussels | 1082 | Belgium | |||
| C-Endo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Diogenes A, Michael AH, Teixeira FB, Hargreaves KM. An update on clinical regenerative endodontics. Endod Top. 2013;28:2-23. |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D017348 | Microscopy, Electron, Scanning Transmission |
| ID | Term |
|---|---|
| D046529 | Microscopy, Electron, Transmission |
| D008854 | Microscopy, Electron |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
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|
| stem and progenitor cells | Biological |
|
on intra-oral bidimensional radiographs: the increase in root canal length.
| 3 years |
| Patient related outcome, measured by a pain-scale | 3 years |
| Microbial diversity in the infected immature root canal | Q-PCR analysis | intraoperative |
| Herent |
| 3020 |
| Belgium |
| Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven | Leuven | 3000 | Belgium |
| EndoVanGorp | Rotselaar | 3110 | Belgium |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |